Evaluating the safety and effects of TBD11 in healthy adults

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose and Multiple Ascending Dose Trial in Healthy Adult Participants to Evaluate the Safety, Tolerability, and Pharmacokinetics of TBD11 With an Open Label (Single Dose) Food Effect Panel

This study is testing a new drug called TBD11 in healthy adults to see if it's safe and how it affects their bodies.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 108 (estimated)
• Ages: 19 Years to 55 Years
• Sex: All
• Sponsor: Bill & Melinda Gates Medical Research Institute (Academic / other)
• Locations: 1 site (Lincoln, Nebraska)
• Trial ID: NCT06707142 on ClinicalTrials.gov

What this trial studies

This trial is a randomized, double-blind, placebo-controlled study designed to assess the safety, tolerability, and pharmacokinetics of TBD11 in healthy adult participants. It consists of two parts: the first part involves single ascending doses and food effect cohorts, while the second part focuses on multiple ascending doses. Participants will receive either the drug or a placebo, and their responses will be closely monitored throughout the trial.

Who should consider this trial

Good fit: Ideal candidates for this study are healthy adults aged 18 to 65 with a BMI between 18 and 32 kg/m².

Not a fit: Patients with pre-existing health conditions or those outside the specified BMI range may not benefit from this study.

Why it matters

Potential benefit: If successful, this trial could provide valuable safety and tolerability data for TBD11, potentially leading to its use in treating various conditions.

How similar studies have performed: Other studies involving similar first-in-human approaches have shown promise, but the specific drug TBD11 is novel and untested in this context.

Eligibility criteria

Inclusion Criteria:

* Is healthy as determined by the Investigator via medical history and clinical examination before enrolment in the trial.
* Can understand and comply with the trial and site procedures, understand the risks involved in the trial, and provide written informed consent before the first trial-specific procedure.
* Can complete all Screening period evaluations and stay in the clinical research facility for the duration of the inpatient periods of the trial.
* Has BMI between 18 and 32 kilograms per meter square (kg/m2), inclusive, and body weight not less than 50 kg at Screening.
* Has resting vital signs within the following ranges:

  1. Systolic blood pressure (SBP) \>= 100 millimeters of Mercury (mmHg) and \<= 140 mmHg
  2. Diastolic blood pressure (DBP) \>= 60 mmHg and \<= 90 mmHg
  3. Heart rate between 50 and 100 beats per minute (bpm)
* If individual's assigned sex at birth is female, they must have negative urine and serum pregnancy tests at Screening, and be of non-childbearing potential based on either of the following:

  1. Is post-menopausal defined as amenorrhea for at least 12 months in absence of any exogenous hormonal treatments and follicle stimulating hormone (FSH) levels in the laboratory-defined postmenopausal range, or,
  2. Reports being surgically sterilized (ie, tubal ligation, hysterectomy, bilateral oophorectomy/salpingectomy), and provides written documentation \[(ie, medical record(s)\], where feasible, to document such procedure(s) to the Principal Investigator. The site must make documented attempts to obtain medical records. If records cannot be retrieved, a participant may be enrolled at the Principal Investigator's discretion.

Exclusion Criteria:

* Has current or past history of a clinically significant cardiovascular, cerebrovascular, respiratory, gastrointestinal, hematologic, renal, hepatic, immunologic, metabolic, urologic, neurologic, dermatologic, psychiatric, or other major disease, as determined by the Investigator.
* Has history of or has clinically relevant cardiovascular disorder, such as heart failure, coronary artery disease, controlled or uncontrolled hypertension, arrhythmia, tachyarrhythmia, prolonged QT syndrome, or presence of symptom(s) strongly suggestive of such a problem, such as exertional chest pressure/pain or unexplained syncope.
* Had an active malignancy within 5 years from Screening, except basal cell or squamous cell skin cancers. Any history of breast cancer or melanoma will be exclusionary.
* Has history of any drug abuse within 1 year prior to Screening or has used any hard drugs (such as cocaine, phencyclidine \[PCP\], natural and synthetic opiates, and amphetamine derivatives) within 1 year prior to Screening. Individuals that have taken an opioid or amphetamine medication within the previous year prior to Screening that was prescribed by a healthcare provider will not be excluded unless they are currently taking the medication at the time of Screening.
* Had any surgical or medical condition or history that, in the opinion of the Investigator, may potentially alter the absorption, metabolism, or excretion of study treatment, such as, but not limited to, gastric bypass, sleeve, banding surgery, or gastric or duodenal ulcers.

Additional inclusion/exclusion criteria are defined in the protocol.

Where this trial is running

Lincoln, Nebraska

• Celerion — Lincoln, Nebraska, United States (Recruiting)

Study contacts

• Study coordinator: Gates MRI

Conditions Healthy Adult Participants; Single Ascending Dose; Multiple Ascending Dose; TBD11; Food Effect; Safety; Tolerability